MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GOLD PROBE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00560101
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental emdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during withdrawal, the tip of the gold probe fell off.The detached tip was withdrawn through scope.The procedure was completed with another gold probe device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b5 was updated with additional information received on 12oct2020.Block a2: the patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: device problem code 2907 captures the reportable event of the tip of the probe fell off.Block h10: investigation results the returned gold probe was analyzed, and a visual evaluation noted that the distal tip detached from the catheter.Additionally, the distal part of the catheter did have some evidence of adhesive and tapping marks.The dimension of the distal tip was measured and was found to be within specification.Based on all available information and the condition of the returned device, this failure mode could be caused due to procedure practices such as user technique, handling or anatomical conditions.The investigation concluded the most probable cause of this event is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during withdrawal, the tip of the gold probe fell off.The detached tip was withdrawn through scope.The procedure was completed with another gold probe device.There were no patient complications reported as a result of this event.***additional information received on october 12, 2020** based on the information received, the distal gold tip separated from the catheter and remained partially attached to the device, but completely detached upon removal outside of the patient.The distal gold tip did not fall inside the patient.
Additional Manufacturer Narrative
Block a2: the patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: device problem code 2907 captures the reportable event of the tip of the probe fell off.Block h10: investigation results: the returned gold probe was analyzed, and a visual evaluation noted that the distal tip detached from the catheter.Additionally, the distal part of the catheter did have some evidence of adhesive and tapping marks.The dimension of the distal tip was measured and was found to be within specification.Based on all available information and the condition of the returned device, this failure mode could be caused due to procedure practices such as user technique, handling or anatomical conditions.The investigation concluded the most probable cause of this event is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a gold probe was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2020.According to the complainant, during withdrawal, the tip of the gold probe fell off.The detached tip was withdrawn through scope.The procedure was completed with another gold probe device.There were no patient complications reported as a result of this event.

• Brand Name: GOLD PROBE
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10347013
• Report Number: 3005099803-2020-02899
• Device Sequence Number: 3293968
• Product Code: KNS
• UDI-Device Identifier: 08714729071020
• UDI-Public: 08714729071020
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K970278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2021
• Device Model Number: M00560101
• Device Catalogue Number: 6010-05
• Device Lot Number: 0023183629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/10/2020; 10/12/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 10/05/2020; 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1